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EVS-EN ISO 22523:2006

External limb prostheses and external orthoses - Requirements and test methods

General information
Valid from 08.12.2006
Base Documents
ISO 22523:2006; EN ISO 22523:2006
ICS Groups
11.040.40 Implants for surgery, prosthetics and orthotics
Directives or regulations
93/42/EEC Medical devices (MDD)
Directive 93/42/EEC (Medical devices) Notice: This standard still needs to be amended to take into account the requirements introduced by Directive 2007/47/EC. The amended standard will be published by CEN as soon as possible. Manufacturers are advised to check whether all relevant essential requirements of the amended directive are appropriately covered.

Standard history

Status
Date
Type
Name
Main
prEN ISO 22523
08.12.2006
Main
EVS-EN ISO 22523:2006
Main
EVS-EN 12523:1999
This International Standard specifies requirements and test methods for external limb prostheses and external orthoses, including the following classifications from ISO 9999:06 03 - 06 15 Orthoses 06 18 - 06 27 Limb prostheses It covers strength, materials, restrictions on use, risk and the provision of information associated with the normal conditions of use of both components and assemblies of components.
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PDF
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Paper
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Standard monitoring
English

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Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English

Contact

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Reg. code 80120020
Eesti Standardimis- ja Akrediteerimiskeskus MTÜ
E-N 8:30-17:00 R 8:30-16:00

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